Dems call on White House to explore sharing Moderna technology abroad

 A group of congressional Democrats is calling on the Biden administration to explore ways to share Moderna’s COVID-19 vaccine technology with other countries, saying more needs to be done to boost global vaccinations. 

“It is imperative for the administration to take bold steps to dramatically expand global vaccine access and manufacturing capabilities as quickly as possible,” the lawmakers wrote in a letter to the Biden administration led by Sens. Elizabeth Warren (D-Mass.) and Jeff Merkley (D-Ore.) and Rep. Pramila Jayapal (D-Wash.).

The three noted that less than 10 percent of the population in low-income countries is vaccinated. 

The lawmakers pointed to the contract between Moderna and the U.S. government as possibly allowing the Biden administration to share the vaccine technology on its own. The letter pointed to a report in The New York Times that Moderna has resisted calls from the administration to act on its own to share its technology.  

“Despite receiving huge sums of public funding from American taxpayers, Moderna has refused calls to share its technology, including from the U.S. government,” the lawmakers wrote. 

“The contract Moderna entered into with the Biomedical Advanced Research and Development Authority (BARDA) may give the federal government legal authority to access and share the ingredient list and manufacturing instructions for Moderna’s COVID-19 vaccine,” they add. 

The letter notes that parts of the contract are redacted, and asks the administration for answers on its authorities.

Aside from the contract with Moderna, some experts, including former Centers for Disease Control and Prevention Director Tom Frieden, have called for the Biden administration to use other authorities, such as the Defense Production Act, to compel transfer of Moderna’s technology to boost vaccine manufacturing in other countries. 

The lawmakers noted that if global vaccinations lag, it gives the virus more chances to form new variants. 

“The virus continues to circulate, with an average of over 438,000 new cases reported daily, risking the evolution of new variants that have the potential to be even more infectious or deadly and, at worst, resistant to existing COVID-19 vaccines,” they write.

https://thehill.com/policy/healthcare/576564-democrats-call-on-white-house-to-explore-sharing-moderna-technology-abroad

White House tells states to prepare plans to vaccinate kids in coming weeks

 The White House coronavirus task force on Tuesday urged state leaders to be ready to begin rolling out COVID-19 vaccination efforts for kids as early as the start of next month.

Administration officials told governors on a regularly scheduled call that school-aged kids could be eligible for the shots by early November and encouraged states to have plans in place to get them vaccinated, a source on the call confirmed.

ABC News first reported that pandemic response coordinator Jeff Zients told governors the White House has enough supply to inoculate roughly 28 million kids between the ages of 5 and 11.

Pfizer last week said it had submitted an application to the Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 vaccine in children ages 5 to 11. An FDA advisory committee is meeting to discuss the application on Oct. 26.

White House press secretary Jen Psaki said Wednesday the administration is preparing messaging and outreach strategies to meet parents where they are and address any concerns or questions about getting their children vaccinated once the shot is approved.

"Parents are going to want to go and ask their doctor questions, ask their pediatrician questions, better understand the safety, the efficacy of the vaccine," Psaki said at a press briefing. "What we will be doing is of course ... empowering local medical experts, pediatricians, doctors who can speak to this, who can answer questions as they have them. We’ll be encouraging people to speak to their doctors."

Pfizer has tested a dose for children that is one-third the amount used in adults. Late last month, it announced positive results from its studies, pointing to a “favorable safety profile and robust neutralizing antibody responses.”

Children generally do not get severely ill with COVID-19 as much as older people do, but there were still almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics, with the highly transmissible delta variant driving a rise in cases among young people in recent months.

https://thehill.com/policy/healthcare/576587-white-house-tells-states-to-prepare-vaccination-plans-for-kids-in-coming

FDA report finds J&J COVID-19 booster beneficial, despite limited data

 A second dose of Johnson & Johnson's coronavirus vaccine is likely beneficial to recipients, the Food and Drug Administration (FDA) said Wednesday, thoughthe data is extremely limited.

In a briefing document released ahead of an advisory panel meeting later this week, the FDA said it relied heavily on studies conducted by Johnson & Johnson and could not independently confirm many of the findings because data from the trials were not submitted in time. 

The staff report indicated that the evidence was likely stronger for the effectiveness of a booster of Johnson & Johnson's vaccine than for the mRNA vaccines from Pfizer-BioNTech and Moderna

"Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary  dose," FDA staff scientists wrote.

In an unusual move, the agency scheduled the meeting of its outside advisers before the company had even submitted its application for a booster dose, leading to the time crunch.

Friday's meeting of FDA's advisory committee will likely conclude with recommendations to the agency about the necessity of a booster dose of the single-shot vaccine and the timing to administer it. 

While touted for its ease of distribution, Johnson & Johnson's vaccine has from the start had a lower effectiveness compared to the mRNA vaccines, leading experts to believe a booster would likely be needed at some point.

"Overall, data indicate that the Janssen COVID-19 vaccine still affords protection against severe  COVID-19 disease and death in the United States, although the highest effectiveness estimates (including for more severe COVID-19 disease) across clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine are consistently less than the highest effectiveness estimates for the mRNA COVID-19 vaccines," FDA staff wrote in the report.

While the vaccine provides protection against severe disease for at least six months, the company said a decrease in protection over time against cases that include moderate COVID-19 was observed globally, which could be driven by waning protection or reduced efficacy against emergent SARS CoV-2 variants.

Vaccine efficacy against moderate and severe/critical COVID-19 decreased from 66.9 percent to 56.3 percent  at the final analysis.

Johnson & Johnson said a booster is recommended "at 6 months or later, based on the strength of the immune responses" for people ages 18 and older. 

However, the company also said a booster may be administered as early as two months after the initial dose, and the advisory panel will discuss that evidence during the meeting.  

The FDA said there was one study that showed a lower increase in antibodies after two months compared to when a booster it was administered after six months, but sensitivity issues with the test used to conduct the analysis means the levels can't be directly compared

FDA scientists also suggested there wasn’t enough data on the older people or on the impact of a booster on the delta variant to draw a definitive conclusion on the benefit. 

The FDA advisory group is scheduled to discuss the J&J data on Friday, after meeting Thursday to discuss the data on Moderna's submission for authorization of a booster. 

Unlike with Johnson & Johnson, the FDA report did not take a position as to the benefit of a booster dose of Moderna, because there's limited evidence that protection is waning. But the panel raised similar concerns regarding Pfizer's booster request, which still ended up being authorized.

The agency could make a final decision within days of the meetings. Then, the Centers for Disease Control and Prevention and its vaccine advisory committee will meet and make their own decision, likely next week.

https://thehill.com/policy/healthcare/576593-fda-report-finds-jj-covid-booster-beneficial-despite-limited-data

Biden official warns Moderna to 'step up' on vaccine doses for the world

 A top Biden administration official on Wednesday warned Moderna to “step up” and provide more vaccine doses for the world, amid pressure on the White House to take more decisive action. 

David Kessler, the chief science officer for the White House COVID-19 response team, revealed during a panel discussion that administration officials have met with the board of Moderna in “recent days” and made a request for greater steps from the company to provide doses for the world, through the World Health Organization-backed organization COVAX. 

He said the administration is still awaiting a response from Moderna, but mentioned the possibility that the administration could use its authorities to compel greater action from the company, though he said no decision had been made. 

“We've been in very, very intense discussions with Moderna,” Kessler said. “There is very substantial capacity through 2022 for them to close and in fact even exceed the COVAX gap, and they need to do that.”

Much of the discussion centered on Moderna, which received significant government funding and assistance in its vaccine development, but Kessler also mentioned that Johnson & Johnson could have room to increase its capacity in the coming months as well. Pfizer has entered a deal with the U.S. government to provide 500 million doses to donate to the world. 

“Do not underestimate the resolve of the United States government in addressing this issue,” Kessler said. “I think these companies understand our authorities, and understand we would not be afraid to use them, but the best recourse right now is for them to step up to the plate now.”

Some experts have been calling on the Biden administration to use authorities under the Defense Production Act to compel vaccine makers to share their know-how with other countries to boost manufacturing. 

Kessler's comments acknowledging those authorities are some of the strongest that the administration has made publicly on the issue. 

Kessler made the remarks while on a panel hosted by the Law and Political Economy Project at Yale Law School.

Other panelists included activists that have been pressing the Biden administration for months to take greater action on global vaccinations, and the discussion grew tense at times as the activists pressed Kessler for more action.

The activists want the administration to use its authorities to compel action from the vaccine makers, saying that months of seeking voluntary steps have not worked, as thousands of people die every day from COVID-19 around the world.

James Krellenstein, co-founder of the group Prep4All, said he had not heard any “concrete” actions from Kessler. 

“We need the U.S. government to take charge,” added Zain Rizvi, of the progressive group Public Citizen. 

Responding to the assertion that the administration had used a “light touch” with vaccine makers, Kessler replied: “This has been anything but light touch, let me assure you.”

After meeting with Moderna on greater steps for global vaccinations, Kessler said, “The United States government has not made a decision yet on what it would do, depending on what the answer is, but we are awaiting an answer.”

Kessler did not detail the administration's request to Moderna, but said that “several billion” doses are needed for the world in the short term. 

Kessler said that vaccine makers have been reluctant to share their closely-held and valuable know-how on how to make their vaccines. 

“Let's not anyone kid each other, at the end of the day, this know-how is an asset to these companies that they are reluctant to give up,” he said. 

Experts warn that without vaccinating the world, the virus has more chances to develop new variants that could evade the current vaccines’ protection. 

A group of Democratic lawmakers earlier on Wednesday also called for the Biden administration to take greater action with Moderna, as pressure mounts. 

Moderna did not immediately respond to a request for comment on Kessler's comments. 

https://thehill.com/policy/healthcare/576599-biden-official-warns-moderna-to-step-up-on-vaccine-doses-for-the-world

CytoSorbents: Prelim Q3 Business Update, Revised 2021 Product Revenue Guidance

 Preliminary third quarter 2021 total revenue was $9.7 million, including product sales of $8.9 million. Preliminary core non-COVID-19 product sales increased 4% Y-Y to approximately $7.8 million.

 CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces preliminary third quarter financial results and revised second half and full year 2021 product revenue guidance, primarily reflecting pandemic-driven adverse market conditions in Germany.

Preliminary Third Quarter 2021 Financial Information

• Total revenue, including product sales and grant income, for Q3 2021 was $9.7 million, down 8% compared to $10.5 million in Q3 2020.

• Q3 2021 CytoSorb product sales were $8.9 million, down 13% compared to $10.2 million in Q3 2020.

• Q3 2021 product sales in Germany are estimated to be $3.7 million, a decrease of $1.1 million or 24%, from product sales of $4.8 million in Germany in Q3 2020.

• Core non-COVID-19 product sales for Q3 2021 were approximately $7.8 million, up 4% from approximately $7.5 million in Q3 2020.

• Estimated product sales related to COVID-19 were $1.1 million in Q3 2021 versus approximately $2.7 million in Q3 2020.

• The Company has a strong cash balance of $61.0 million at September 30, 2021 and no debt.

CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance

The third largest wave in new COVID-19 cases in Germany, driven by the Delta variant, accelerated through August and, after peaking in mid-September, has continued to date. This prompted many hospitals throughout Germany to reduce elective surgical procedures, to reserve ICU beds, and to either maintain or reinstitute restrictions such as visitation rights to non-essential visitors, in preparation of COVID-19 hospitalizations. However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring ICU care, and death have been disproportionately very low. This is being partly attributed to high rates of vaccinations that are associated with reduced severity of illness, reduced need for hospitalization, and risk of death.

We believe the revised guidance below is achievable, as in deriving the revised fourth quarter and full year product revenue outlook, we have assumed no improvement in the COVID-19 pandemic-related environment observed during the third quarter of 2021. In addition, we do not have full visibility into the potential impact of the recently released data from the REMOVE study, as full study results are not yet available. Though we believe that CytoSorb will continue to be used in selected infective endocarditis populations, we have included a potential negative impact to sales in our guidance. As a result, the Company now expects:

• Q4 2021 product revenue similar to Q3 2021 product revenue of $8.9 million, suggesting approximately $17.8 million in second half product sales, down 17% from first half 2021 products sales, as compared to previous expectations of higher second half 2021 product sales compared to first half 2021 product sales.

• Full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020 product revenue of $39.5 million. While difficult to predict, 2021 core non-COVID-19 product sales are expected to be approximately $33 to $34 million for the year versus $30.1 million in 2020.

https://finance.yahoo.com/news/cytosorbents-provides-preliminary-third-quarter-203500933.html

Sono-Tek Sees Double-Digit Growth, Record Sales for FY 2022

  Sono-Tek Corporation (NASDAQ: SOTK), the leading developer and manufacturer of ultrasonic coating systems, today reported financial results for the second quarter and first half periods of fiscal year 2022, ended August 31, 2021.

Second Quarter FY2022 Financial Highlights:
(Compared with prior-year period unless otherwise noted)

• Net sales were $4,070,000, up 17% or $589,000, driven by increased sales of OEM systems to the China market.

• Gross Profit increased 28% to $2,074,000 due to higher sales and product mix.

• Gross Margin expanded 440 basis points to 51.0% primarily due to product mix.

• Operating income increased 123% to $449,000, compared to $201,000.

• Net income was $344,000, an increase of 93%.

• Backlog reached a record high of $6,332,000, an increase of 45% compared with backlog of $4,380,000 on May 31, 2021 (the end of the fiscal Q1) and increased 64% compared to backlog of $3,851,000 on February 28, 2021 (the end of fiscal 2021).

• Uplisted to Nasdaq Capital Market on August 27, 2021.

First Half Fiscal 2022 Highlights
(Compared with prior-year period unless otherwise noted)

• Net Sales were $7,715,000, an increase of 12%, primarily driven by strength in the semiconductor and electronic diagnostic coating markets.

• Gross Profit increased 23% to $3,898,000 due to higher sales and product mix.

• Gross Margin expanded 440 basis points to 50.5% primarily due to product mix and lower than expected warranty and installation costs.

• Operating Income increased 105% to $791,000 due to increases in gross profit, partially offset by increases in operating expenses.

• Income before taxes increased 94% to $802,000, excluding the benefit from PPP loan forgiveness of $1.0 million.

• As of August 31, 2021, the Company had no outstanding debt.

Guidance

• Sales Growth Guidance for the third and fourth quarters of FY2022 is for double digit increases over the comparable periods of last year.

• Sono-Tek continues to expect the highest annual sales in corporate history for fiscal year 2022, ending February 28, 2022.

Dr. Christopher L. Coccio, Chairman and CEO, commented, “Sono-Tek had another strong performance in the second quarter of fiscal 2022. Net sales increased 17% with strength in multi-axis coating systems and the OEM markets for semiconductor and fluxing systems. The electronics/microelectronics segment again accounted for a large portion of the quarter’s sales, 36% compared to 23% in the second quarter of last fiscal year, driven by sales of systems for diagnostic coatings on electronic devices for COVID-19 test kits and the ongoing global shortages and investments in semiconductors. Approximately 62% of sales originated outside of the US and Canada in the quarter. APAC accounted for 65% of foreign sales, led by sales to China. We expect continued international growth as countries around the world roll back COVID-19 restrictions and bring manufacturing capacity back online. We’ve already begun to see increased activity in our global network of process development labs. We effectively contained costs in the quarter and the product mix was favorable, enabling a 28% increase in gross profit to $2.1 million and a 440 basis point expansion in gross margin to 51.0%. Operating income more than doubled and net income increased 93%. Backlog reached a record high of $6.3 million, an increase of 45% from the end of the first quarter and an increase of 64% from the end of our last fiscal year on February 28, 2021.

https://finance.yahoo.com/news/sono-tek-reports-strong-growth-120000061.html

Clarus started at Buy by Truist

 Target $10

https://www.marketbeat.com/stocks/NASDAQ/CRXT/price-target/